FDA WARNING_LETTER - Myle Vape, Inc. - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Ariel Gorelik, identifying that the website https://www.mylevapor.com manufactures and sells Electronic Nicotine Delivery System (ENDS) products. These products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date, requiring a marketing authorization order or substantial equivalence determination.

The FDA's review found that products such as Mylé Mini – Iced Lychee Disposable Device and Mylé Mini 2 – Cubano Disposable Device, among others, are new tobacco products that lack the necessary FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of violative products and a plan for future compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.